Exec Medical Director, Pharmacovigilance Risk Management (PVRM)

Exelixis•Alameda, CA

30d

About The Position

The Executive Medical Director, PVRM is responsible for the development and execution of the global product safety strategy for complex clinical development program(s) as well as post-marketing pharmacovigilance activities for Exelixis products. This role leads and mentors team members to proactively and successfully plan and manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross-functionally to execute on the corporate development strategy. ESSENTIAL DUTIES AND RESPONSIBILITIES: The incumbent operates in a matrix environment within the global patient safety function and the broader development organization. Responsibilities for this position include: Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization. Create appropriate safety data analysis strategies across clinical studies for a product. Perform appropriate data interpretation on the performed safety analyses for a product. Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents). Lead the cross-functional Benefit Risk Team for the assigned product and escalate important safety updates to the Benefit Risk Executive Committee in a timely fashion. Lead the development of core safety documents, which characterize the safety profile of the product appropriately. Lead proactive safety data reviews and anticipate safety concerns for the assigned product. Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the product. Present safety data and provide safety expertise on the product during key meetings (e.g., with Health Authorities, Data Safety Monitoring Boards and Investigators). Develop risk management strategies and monitoring plans for risk management effectiveness for the product. Co-lead the benefit-risk assessment for the product with other functions.

Requirements

M.D. degree and a minimum of 10 years of post-residency experience; or, Equivalent combination of education and experience.
At least 10 years of experience of pharmacovigilance experience or other relevant experience (e.g., Clinical Research) in a pharmaceutical/biotechnology company.
Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.
Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices throughout the entire product lifecycle
Extensive knowledge of US and international pharmacovigilance regulations, with experience in their practical application throughout the entire product lifecycle
Demonstrates advanced skill and keen insight in gathering, analyzing and applying key information to solve complex problems
Demonstrates strong organizational and planning capabilities by managing time, workload and resources of a function
Leads and manages a functional area within a department to execute on team functional objectives that contribute to accomplishing common functional and departmental goals
Demonstrates high standards of verbal and written communication. Selects communication method and medium appropriate to the message and the audience. Speaks clearly and confidently in one-to-one situations and effectively presents to large audiences within and outside Exelixis.
Strong interpersonal skills and ability to incorporate differing views to resolve challenges and develop agreed upon resolutions
Develops procedures, tasks and tools. Trains staff on departmental products, tools and data sources. Develops and maintains knowledge of cross-functional products, tools and data sources.
Mentors junior team members.

Nice To Haves

3+ years of clinical experience post-residency
Board Certification (if US) preferred
Significant clinical experience may compensate for shorter experience in pharmaceutical/biotech company
Pharmacovigilance experience in Oncology is a plus.
Prior project and team leadership/management experience is preferred.
Contributes to performance reviews and professional development plans of team members.

Responsibilities

Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization.
Create appropriate safety data analysis strategies across clinical studies for a product.
Perform appropriate data interpretation on the performed safety analyses for a product.
Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
Lead the cross-functional Benefit Risk Team for the assigned product and escalate important safety updates to the Benefit Risk Executive Committee in a timely fashion.
Lead the development of core safety documents, which characterize the safety profile of the product appropriately.
Lead proactive safety data reviews and anticipate safety concerns for the assigned product.
Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the product.
Present safety data and provide safety expertise on the product during key meetings (e.g., with Health Authorities, Data Safety Monitoring Boards and Investigators).
Develop risk management strategies and monitoring plans for risk management effectiveness for the product.
Co-lead the benefit-risk assessment for the product with other functions.